Device product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Z-1000-2026
Product summary
- Event
- Event 98060
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 132 units
- Official record key
device-enforcement:Z-1000-2026
Official wording
Reason: Devices are not suitable for organ transplant.
Code information: Kit Code: LLOG1000-15; UDI: 10809160432679; Lot No: 1632138 & 1648393.
Distribution pattern: US Nationwide distribution in the states of FL, GA and Puerto Rico.
Derived failure modes
-
Unknown
Devices are not suitable for organ transplant.